An observational study in Multiple Myeloma and Non-eligible for Autologous Stem Cell Transplantation (ASCT), sponsored by PETHEMA Foundation. Status unknown at 32 sites in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-09-16.
Sponsored by PETHEMA Foundation · Observational
This is a prospective, observational, single group and multicenter study to describe the effectiveness and safety of maintenance with V-Dara after induction with the VMP-Dara regimen in newly diagnosed MM patients who are not eligible for ASCT.
Patients will be enrolled in the study during a regularly scheduled office visit in clinical practice (screening and enrollment visit) and followed during 3-4 years in what will be called the Observational Phase. During this phase, the patient will be followed by his/her doctor as per routine clinical practice, according to his/her disease. The patient will not suffer any changes in his/her treatment or follow-up due to his/her participation in the study. The patient will receive standard clinical practice and he/she will not do any other study-specific visit.
During this 3-4-year observational phase, the patient might discontinue V or V-Dara,depending on toxicity, efficacy or due to other medical reasons, according to his/her physician decision.
This is a prospective, observational, single group and multicenter study to describe the effectiveness and safety of maintenance with V-Dara after induction with the VMP-Dara regimen in newly diagnosed MM patients who are not eligible for ASCT.
Patients will be recruited only if patients have received induction therapy with VMP-Dara followed by V-Dara as maintenance therapy for at least one cycle prior to the start of the study (treatment has to be previously decided as part of clinical practice). This way, patients must have already been treated with 9 cycles of VMP-Dara (approximately 12 months) and at least 1 cycle of V-Dara maintenance (1 month), before entering the study. This implies that the decision to prescribe this maintenance schedule is clearly unrelated to the decision of enrolling the patient into the study.
Patients will be enrolled in the study during a regularly scheduled office visit in clinical practice (screening and enrollment visit) and followed during 3-4 years in what will be called the Observational Phase. During this phase, the patient will be followed by his/her doctor as per routine clinical practice, according to his/her disease. The patient will not suffer any changes in his/her treatment or follow-up due to his/her participation in the study. The patient will receive standard clinical practice and he/she will not do any other study-specific visit.
Observational Phase:
Patients will be followed for 3-4 years since the inclusion in the study. Once the patient is enrolled in the study, retrospective data collection at the start and end of VMP-Dara induction will be collected. Subjects who discontinue maintenance therapy before disease progression (V or V-Dara), will continue to have response rate evaluations, PFS and toxicity recorded as per routine clinical practice, until the end of the study or progression, whatever comes first.
During this observational follow-up, both the duration of the initially prescribed V-Dara maintenance (and the time when bortezomib is stopped before daratumumab if this ever happens), the existence of potential adverse reactions and the fate of the disease in terms of progression and survival, even though the maintenance only daratumumab could have been stopped, will be documented for a total of up to 3-4 years. Maintenance with V-Dara, or just daratumumab once bortezomib is suspended, can be finalized due to progression, unacceptable toxicity or voluntary withdrawal.
This observational study has the following objectives:
Primary Objective:
- To describe the effectiveness of V-Dara maintenance after VMPDara induction in patients with MM non-eligible for autologous stem cell transplantation in the Spanish clinical setting (clinical practice).
Secondary Objectives:
3,712 studies on the registry are indexed under Multiple Myeloma; 752 are open to participants now.
This study's planned enrollment of 100 is below the median of 145 across 482 observational studies indexed under Multiple Myeloma.
Browse Multiple Myeloma studies →PETHEMA Foundation is the lead sponsor of 106 studies on the registry; 11 are open to participants now.
Counted across the registry records on this site, refreshed daily.
A target of approximately 100 subjects from the centers opened in the study will be recruited only if patients have received induction therapy with VMP-Dara followed by V-Dara as maintenance therapy for at least one cycle prior to the start of the study (treatment has to be previously decided as part of clinical practice). This way, patients must have already been treated with 9 cycles of VMP-Dara (approximately 12 months) and at least 1 cycle of V-Dara maintenance (1 month), before entering the study. This implies that the decision to prescribe this maintenance schedule is clearly unrelated to the decision of enrolling the patient into the study.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Maintenance with bortezomib plus daratumumab (V-Dara) after induction with bortezomib, melphalan, prednisone plus daratumumab (VMP-Dara)
Drug: Bortezomib · Drug: Daratumumab
Maintenance: Administration as per routine clinical practice.
Maintenance: Administration as per routine clinical practice.
Progression Free Survival (PFS)
Time from the start of induction with VMPDara until disease progression or death, whichever comes first
Time frame: Throughout the study period. Approximately 4 years
Description of MRD status and depth
Description of MRD status and depth, that will be conducted on bone marrow samples and outside of the bone marrow through imaging techniques if available per routine clinical practice, according to the investigator's criteria.
Time frame: Throughout the study period. Approximately 4 years
Stringent Complete Response (sCR) rate
Time frame: Throughout the study period. Approximately 4 years
Complete Response (CR) rate
Time frame: Throughout the study period. Approximately 4 years
Proportion of subjects who achieve Very Good Partial Response (VGPR) or better
Time frame: Throughout the study period. Approximately 4 years
Overall Response Rate (ORR)
Time frame: Throughout the study period. Approximately 4 years
Duration of response
Duration of response calculated from the date of initial documentation of a response (CR or PR) to the date of first documented evidence of progressive disease.
Time frame: Throughout the study period. Approximately 4 years
Time to Progression (TTP)
Time to Progression (TTP), defined as the time from the date of start of VMP-Dara to the date of first documented evidence of PD.
Time frame: Throughout the study period. Approximately 4 years
Incidence of adverse events (AEs)
Number of patients experiencing AEs, classified according to severity.
Time frame: Throughout the study period. Approximately 4 years
Plan to share: No
This study is status unknown, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.
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